U.S. patent application number 11/922296 was filed with the patent office on 2009-12-17 for device for gastric feeding and drainage via an artificial stoma.
This patent application is currently assigned to KIMBERLY-CLARK WORLDWIDE, INC.. Invention is credited to Lanita Grayce Cox, Fred Gobel, Donald Jay McMichael.
Application Number | 20090312701 11/922296 |
Document ID | / |
Family ID | 37513449 |
Filed Date | 2009-12-17 |
United States Patent
Application |
20090312701 |
Kind Code |
A1 |
Gobel; Fred ; et
al. |
December 17, 2009 |
Device for Gastric Feeding and Drainage Via an Artificial Stoma
Abstract
The invention describes a closure device for the provision of
freshly created gastric feeding fistulas, the basis of the design
of the device being an introverted balloon that allows a sealing
and hemostatic axial traction movement on the fistula that is to be
sealed, the concentric balloon ends which run transmurally through
the stomach and abdominal wall being arranged in a special
seal-promoting and hemostatic manner.
Inventors: |
Gobel; Fred; (Wilhelmsfeld,
DE) ; McMichael; Donald Jay; (Roswell, GA) ;
Cox; Lanita Grayce; (Suwanee, GA) |
Correspondence
Address: |
KIMBERLY-CLARK WORLDWIDE, INC.;Catherine E. Wolf
401 NORTH LAKE STREET
NEENAH
WI
54956
US
|
Assignee: |
KIMBERLY-CLARK WORLDWIDE,
INC.
Neehan
WI
|
Family ID: |
37513449 |
Appl. No.: |
11/922296 |
Filed: |
June 14, 2006 |
PCT Filed: |
June 14, 2006 |
PCT NO: |
PCT/EP2006/005733 |
371 Date: |
December 14, 2007 |
Current U.S.
Class: |
604/96.01 |
Current CPC
Class: |
A61M 2039/0255 20130101;
A61J 15/0015 20130101; A61M 2039/0294 20130101; A61J 15/0057
20130101; A61B 17/3423 20130101; A61B 17/3468 20130101; A61J
15/0065 20130101; A61J 15/0042 20130101; A61M 39/0247 20130101;
A61J 15/0092 20130101; A61M 2039/0276 20130101; A61B 17/3431
20130101 |
Class at
Publication: |
604/96.01 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 17, 2005 |
DE |
10 2005 028 428.0 |
Claims
1. A device (10) for the creation of an artificial stoma (18) into
and subsequent fluid transfer to or from a living body (20)
comprising: a thin foil (22) having a first and a second end (24,
26) with a length (28) disposed therebetween, the thin foil (22)
being arranged in a manner such that one of said ends is backfolded
or introverted into the other of said ends; and a cap (30) having
at least one port (34) therethrough, the cap (30) securely
capturing each end (24, 26) of the foil (22) therein, the port
terminating between the first and second foil ends (24, 26) within
a space (32) created by introversion of the foil (22) so that
application of an inflation source (44) to the port (34) causes the
length (28) of said foil (22) to inflate and form a generally torus
shaped balloon (36) having exterior and interior externally facing
concentric surfaces (38, 40), the cap (30) situated at one end of
the balloon (36).
2. The device (10) of claim 1 comprising a bore (50) through the
cap (30) in communication with a passage (42) formed by the
interior externally facing surface (40) which passes through the
interior of the device (10).
3. The device (10) of claim 1 or 2 wherein the torus shaped balloon
(36) is adapted to exert an increasingly greater force upon
increasing inflation, the force being exerted axially along the
foil (22) and directed toward the cap (30).
4. The device of any of the preceding claims comprising an
insertion device (66) for placing the foil (22) in a deflated state
within the living body (20) and situating the cap (30) adjacent a
body surface at the stoma (18).
5. The device of claim 4 wherein the insertion device (66)
comprises a user manipulable introducer (68) and a capturing
element (80), the introducer (68) comprising a tapered probe (70)
having a cavity (78) therein within which the foil (22) is
temporarily captured, the capturing element (80) sized to fit
frictionally within the bore (50) and in conjunction with the foil
(22) retain the introducer (68) in position proximate to the cap
(30).
6. The device (10) of claim 5 comprising an extension rod (76)
affixed to the introducer (68), the extension rod (76) enabling the
tapered probe (70) to be inserted deeper into the living body (20)
until the foil (22) is disengaged from within the cavity (78)
without affecting the position of the cap (30) or the capturing
element (80).
7. The device (10) of claim 6 wherein the introducer (68) is
removed from the living body (20) via the passage (42) and bore
(50) subsequent to the inflation of the balloon (36) and removal of
the capturing element (80).
8. The device (10) of any of the preceding claims adapted to be
placed in the living body (20) by engaging a guide wire previously
situated in the living body (20).
Description
PRIORITY
[0001] This patent application claims priority to currently
copending German National Application DE 10 2005 028 428.0 entitled
"Vorrichtung zur gastrischen Emahrung und Drainage uber eine
transkutan angelegte Fistel" filed on Jun. 17, 2005 by Microcuff,
GmbH having Dr. Fred Gobel named as inventor.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to a device for creating and
maintaining an artificial stoma enabling access to a body cavity,
such as used in the direct feeding of a patient's stomach. More
particularly, the present invention relates to a device for
percutaneously placing various gastric catheters, forming
artificial stomas capable of accessing the gastrointestinal tract,
and ultimately providing a gastric feeding capability. Beyond the
initial placement procedure, the device meets the requirements for
permanent placement in the patient, such that when used for enteral
feeding, the device enables a low-force, dynamically
self-adjusting, directed seal between the inside of the stomach or
gastric wall and an external body surface, i.e., the outside of the
abdominal wall.
[0003] In particular, the invention addresses the problem of the
seal or permanent fusion of the tissues surrounding the stoma that
needs to be established between the abdominal cavity and the inside
of the stomach immediately after the surgical creation of the
fistula, i.e., during the initial insertion of the catheter. It
also is concerned with ways in which subsequent to placement, the
catheter can be changed simply and atraumatically, even by a
trained layperson, without damaging the stoma site.
[0004] It is recognized that numerous medical conditions exist in
which it becomes necessary to gain percutaneous access to viscera
such as the stomach or small intestines. Situations where a patient
has lost the ability to swallow and will require long term
nutritional support may dictate feeding directly into the stomach
or jejunum. Feeding in this manner may be accomplished by inserting
a feeding tube into the patient's stomach such that one end remains
anchored in the stomach, while the other end remains external to
the patient's body for connection to a nutrient source. A variety
of different feeding tubes or catheters intended for enteral
feeding have been developed over the years, including some having a
"low profile" relative to the patient during use and those having
the more traditional or non-low profile configuration.
[0005] Such feeding tubes may be inserted into a patient's stomach
in a number of ways. Feeding tubes may be endoscopically placed,
surgically placed through an open incision, laproscopically placed,
or percutaneously placed under endoscopic, fluoroscopic or
ultrasonic guidance. Different types of feeding tubes may be placed
using these procedures, examples include gastrostomy, jejunostomy
or gastro-jejunostomy. These tubes may be retained in the lumen
(stomach or intestine) with a variety of retention anchors. These
anchoring mechanisms include: inflatable balloons, obturatable
domes, fixed dome-type bumpers, or suture wings.
[0006] It is known that many of the catheters on the market today
are commonly referred to as "replacement" catheters because they
are substituted for an enteral feeding tube that is initially
placed in a patient for six to eight weeks until a fistula stoma
tract is established. Once the stoma tract is established, the
initial placement device is generally removed, and the
"replacement" enteral feeding device is inserted into the stoma
tract. Historically, prior to placing the actual enteral feeding
device, it has been preferred to perform a gastropexy procedure
during placement. This procedure enables the physician to attach
the visceral wall to the abdomen and to create the stoma tract
through the two. This attachment is critical to prevent inadvertent
separation and exposure of the peritoneal cavity to contamination
and possible peritonitis.
[0007] Initial placement devices are often not readily removable
without additional invasive surgical procedures. That is, many
initially placed enteral catheters contain rigid retention members
which cannot readily be passed through the stoma of the patient
when it is desired to remove the initially placed device. Typically
the t-shaped fastener or t-bar is not removable and is left in the
body cavity where it is allowed to pass naturally in the patient's
stool. In many cases the t-bar is not passed and remains within the
body cavity. Moreover, during the six to eight weeks it takes for
the fistula's stoma tract to be established, the anchoring
mechanism of the prior art gastropexy device which typically
consists of a small metal t-shaped fastener may embed itself into
the gastric or intestinal wall and ultimately lead to infection.
Furthermore, the t-bar itself may have sharp edges which can be
uncomfortable for the patient.
[0008] In many of these procedures, in order to achieve the desired
seal between the stomach and the abdominal wall, a traction force
must be applied to the anchoring mechanism. The force is applied in
such a way as to pull the stomach cavity to the abdominal wall so
that the penetration through both may heal together thereby
creating the passage or stoma leading from the patient's stomach,
through the abdominal wall, to an external environment. It is
necessary to apply this traction force for a period of a couple of
days through a couple of weeks until the stoma site adequately
heals. During this period the patient has reduced mobility which
may lead to additional post-operative complications.
[0009] There is a need and desire for a device which may be used
during initial placement or creation of a stoma site and which also
may serve as the "replacement" enteral feeding device itself Such a
device would foster the permanent fusion of the stomach wall to the
abdomen; it would replace standard catheter placement technology
and thus substitute a single step procedure for the standard
multi-step procedure. This would serve to reduce the invasiveness
of the procedure, greatly enhance wound healing, and enable
immediate, post-placement gastric access for feeding and drainage,
and ultimately allow atraumatic exchange of the low profile
device.
SUMMARY OF THE INVENTION
[0010] In response to the foregoing problems and difficulties
encountered by those of skill in the art, the present invention is
directed toward a device for the creation of an artificial stoma
into and subsequent fluid transfer to or from a living body. Such a
device may provide the following advantages: it would foster
approximation of the gastric wall and abdominal wall in a
sufficiently large area to enable tissue fusion; it would reduce
the number of punctures to only one transcutaneous gastric puncture
or incision; it would create a self-adjusting seal with respect to
the puncture site and do so while taking into account body movement
and resulting sheer forces; it would provide secure anchoring even
under high pull-forces; it would reduce or prevent initial leakage
or bleeding from the puncture channel thus reducing the likelihood
of peritoneal infections; it would allow immediate access to the
stomach and maintain the initial and continuous dilation of the
puncture channel; it would reduce the risk of ulceration within the
gastric lumen due to low-pressure filling of the balloon; it would
enable enhanced patient mobility and comfort; and it would provide
one device, meeting the requirements of both initial and long-term
placement.
[0011] The above-mentioned problems and difficulties can be solved
by a device according to independent claim 1. Further advantageous
features, aspects and details of the invention are evident from the
dependent claims, the description, and the drawings.
[0012] The device in one embodiment would include a thin foil
having a first and a second end with a length disposed
therebetween. The thin foil would be arranged in a manner such that
one of said ends is backfolded or introverted into the other of
said ends. A cap having at least one port therethrough would also
be provided. The cap would securely capture each end of the foil.
The port would terminate between the first and second foil ends
within a space created by introversion of the foil. By application
of an inflation source to the port, the length of the foil would
inflate and form a generally torus shaped balloon having both
exterior and interior externally facing concentric surfaces. The
cap is situated at one end of the balloon.
[0013] In many embodiments, the device would contain a bore through
the cap so that communication with a passage formed by the interior
externally facing surface may be had. Such communication would pass
through the interior of the device. In many embodiments, the torus
shaped balloon may be adapted to exert an increasingly greater
force upon increasing inflation, the force being exerted axially
along the foil and directed toward the cap.
[0014] Some embodiments may be provided with an insertion device
used for placing the foil in a deflated state within the living
body and situating the cap adjacent a body surface at the stoma.
The insertion device may contain a user manipulable introducer and
a capturing element. The introducer may be configured as a tapered
probe having a cavity therein within which the foil is temporarily
captured. The capturing element would be sized to fit frictionally
within the bore and in conjunction with the foil would retain the
introducer in position proximate to the cap. An extension rod may
be affixed to the introducer. The extension rod would enable the
tapered probe to be inserted deeper into the living body until the
foil is disengaged from within the cavity. This could be
accomplished without affecting the position of the cap or the
capturing element To remove the introducer, the balloon is inflated
and the introducer is extracted from the living body by passing it
out via the passage and bore, again, subsequent to inflation of the
balloon and removal of the capturing element.
[0015] The device in any of its embodiments may be adapted to be
placed in the living body by engaging a guide wire previously
situated in the living body, a process known and understood by
those of skill in the art.
[0016] According to one specific embodiment, the present invention
relates to a device for supplying patients by means of a
transcutaneous fistula (stoma) for direct feeding into the stomach,
comprising a balloon which is backfolded in itself, whereby the
inner end of the balloon serves as an open lumen for inserting a
feeding catheter therethrough, whereby moreover an axially oriented
tractive force acts between the balloon and the ends of the
balloon, which causes a force component pressing the inner
abdominal wall onto the stomach, and whereby on the body surface a
disc element and/or a diameter of the outer one of the two
concentric ends of the balloon, enlarged at least about 25%
compared to the ratio of the diameter of the fistula, serves as a
bearing for an axially oriented back rolling of a torus onto the
inner stomach wall. Specifically, the diameter of the outer of the
two concentric ends of the balloon may be larger than about 50 to
about 75% of the fistula.
[0017] Other objects, advantages and applications of the present
invention will be made clear by the following detailed description
of a preferred embodiment of the invention and the accompanying
drawings wherein reference numerals refer to like or equivalent
structures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 depicts an illustrative view of one embodiment of the
present invention.
[0019] FIGS. 2 and 3 depict intermediate steps in the creation of
the backfolding principle described in many of the embodiments of
the present invention.
[0020] FIG. 4 depicts an alternative embodiment of the FIG. 1
device.
[0021] FIG. 5 depicts an alternative embodiment of the FIG. 1
device having a second embodiment of a useful retention
mechanism.
[0022] FIGS. 6 and 7 depict further embodiments of the device
incorporating features from the FIG. 1 device as well as the second
embodiment of retention mechanism.
[0023] FIG. 8 depicts yet another embodiment of the device
incorporating a third embodiment of the retention mechanism.
[0024] FIG. 9 depicts an insertion device adapted to be used with
the FIG. 8 embodiment.
[0025] FIG. 10 depicts a channel enabling venting of the device;
such a channel may be used on any embodiment of the device
described herein.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0026] In response to the foregoing challenges that have been
experienced by those of skill in the art, the present invention is
directed toward making initial feeding catheter placement less
invasive and more comfortable for the patient The invention is
intended to reduce complications associated with enteral feeding
and the initial placement of the enteral feeding device such as
bleeding or leakage of gastric fluids. It provides a single device
capable of accommodating both the procedure of placement and
long-term wear and use which addresses the needs associated with
initial as well as prolonged placement of the catheter.
[0027] To solve these problems, the invention envisions an
introverted or backfolded balloon arrangement similar to that
described, in a basic form, in WO 2004/069057 to Dr. Lothar Gobel,
which is incorporated filly herein by reference. It should be
understood that the introversion of one end of a balloon element
through the opposite end produces a "torus" shape. In the inflated
state, this torus structure has the tendency to move the balloon
ends into a median plane of the torus ring. A tractive force
operates axially between the balloon and the balloon ends, thus
serving, in the present invention, as an important basic functional
element.
[0028] If the balloon ends are passed through the fistula channel
and secured outside the body on the outside wall of the abdomen
within a fixing cap element, the resulting axial tractive force
would generate a force component capable of pressing the stomach
against the inside wall of the abdomen. This would permit the
permanent fusion of the two tissue layers which prior to this
device would have necessitated a separate treatment step prior to
the actual placement of the enteral feeding device and
intra-gastric access channel through the fused tissue. This torus
shaped closing element would also allow immediate access to the
stomach through a free central lumen of the element. This lumen may
be used for immediate feeding, drainage or insertion of a catheter
therethrough.
[0029] An initial version as well as alternative embodiments of
such a device has been described in DE 10 2005 028 428.0 entitled
"Vorrichtung zur gastrischen Ernahrung und Drainage uber eine
transkutan angelegte Fistel" and was filed on Jun. 17, 2005 by Dr.
Fred Gobel. As such, this disclosure is also fully incorporated
herein by reference and this application claims priority
thereto.
[0030] Looking now to FIG. 1, a device 10 in accordance with the
present invention is depicted. FIG. 1 depicts the spatial
relationships between the device 10 and the adjacent organs to it:
the gastric wall 12, the abdominal wall 14 and the anatomical
fusion site 16 between the two wall structures 12 and 14, where the
perforation forming the fistula or stoma 18, in a patient's living
body 20, is situated. At this point, it should be understood that
for convenience the description of the device will generally be
directed toward accessing the stomach, for example, to enterally
feed a patient. However, the devices as shown and described herein
may also be used to create a communication between two cavity
located organs, spaces or structures, or one cavity located organ,
space or structure and an external environment. As such, no
limitations specifically requiring the invention to be associated
with enteral feeding or gastric access should be read into the
specification.
[0031] In many of the contemplated embodiments, the device 10 is
formed from a thin foil 22 having first and second ends 24 and 26
respectively. As shown in FIG. 2, the foil 22 may be cylindrical in
shape and have a length 28 disposed between the ends 24 and 26,
which along with the ends may define a three-dimensional volumetric
space bounded by a surface or surfaces formed by the foil itself.
Among the simplest of volumetric spaces is the cylinder, as shown.
However, other contemplated volumetric shapes may include the
sphere, cube, cone, cylinder, and more generally, the
polyhedra.
[0032] In common embodiments, and referring to the cylindrical
embodiment of FIG. 2 in particular, FIG. 3 depicts one of the ends
of the foil 22 being backfolded or introverted into the other, for
example, end 26 may be backfolded into end 24 such that end 26 is
situated within end 24. Of course, this configuration may be
switched with end 24 situated within end 26 and still perform in
accordance with the invention.
[0033] In any event turning back to FIG. 1, it may be seen that by
capturing the ends 24 and 26 within a cap 30, an interior space 32
is created. This space 32 is created by the introversion of the
foil 22 itself and may be seen to be defined by its length 28 and
bounded by its ends 24 and 26. Providing the cap 30 with a port 34
that terminates within this space 32 between the first foil end 24
and the second foil end 26 creates a torus shaped structure or
balloon 36 having exterior and interior externally facing surfaces
38 and 40 respectively. The space 32 forms the interior of the
balloon 36 and is adapted to inflate and deflate upon application
or removal of a fluid source such as air, water, or saline. Other
fluids may be used and would be understood by those of skill in the
art.
[0034] The surface 38 may be seen to be an externally facing,
exterior surface of the balloon 36. The surface 40 is also an
exterior surface, however, it is considered an internally facing,
exterior surface of the balloon in that it forms a passage 42
through the center of the torus shaped balloon yet does not enter
the space 32. The diameter of this passage 42 formed by the surface
40 in many embodiments is smaller than the puncture channel through
the gastric 12 and abdominal wall 14. The diameter of the passage
42 determines the flow-characteristics through the device. Further,
secondary catheter elements, described below, may be inserted into
the passage 42 if desired.
[0035] In order to inflate the balloon 36, an inflation source or
mechanism 44 of some kind should be capable of connection to the
port 34. As stated above, the fluid used to inflate the balloon 36
may be a suitable gas or liquid, such as air or saline. A retention
mechanism 46 may also be provided in order to hold the device 10
properly within the living body 20. Such a retention mechanism 46
is envisioned to have numerous possible configurations each of
which will be discussed at greater length in this specification. In
a first embodiment, the retention mechanism 46 may be configured as
a simple disc, button, or retaining ring 48. The retaining ring 48
may be secured to the cap 30 or to the balloon 36 itself via a
friction fit and may simply be adapted to slidably attach to the
exterior of the device in some manner so that it may be slid
against the skin of the abdominal wall of the patient when in
place.
[0036] A bore 50 through the cap 30 connects the passage 42 to an
external environment. The bore 50 forms an opening through which
fluids may pass into or out of the living body 20. In many
embodiments, the bore 50 enables the injection of enteral feeding
solutions. It may also be used to vent gases or other fluids from
within the cavity as described in more detail below. However, in
any of the embodiments described, dedicated pathways may be
provided, one for feeding and one for venting. This concept would
be readily understood by those of skill in the art and may be
accommodated by numerous configurations including but not limited
to the insertion of a dedicated catheter 52 through the bore 50,
through the passage 42, and into the stomach or other organ within
which the device is in communication. Such a catheter may be seen
in FIGS. 5 through 7 which will be further described below. The
catheter 52 may have dual lumens, one for feeding and one for
venting. Alternatively, the catheter 52 may be used for one of the
functions whereas the other function is performed by ensuring that
there is ample room between the exterior of the catheter and the
passage 42 and/or bore 50 diameters.
[0037] Referring generally back to this principle of an introverted
foil 22 forming a torus shaped balloon 36, it may be seen that this
is an improvement over the prior art devices currently in
existence. For example, it should be noted that the present device
10 forms a shaftless catheter structure which effectively
eliminates the need for the prior art rigid shaft elements. It
should also be understood by those of skill in the art that unlike
a balloon bearing a rigid shaft, the present invention may be
reduced to a collapsed tape-like structure when in the deflated and
evacuated state. With such a device 10, it would be possible to
insert the balloon portion 36 through the stoma 18 and into the
living body 20 via a low-invasive, small bore access
penetration.
[0038] Furthermore, due to the controllable collapsibility of the
device 10 it is more amenable to atraumatic removal from the stoma
than are prior art devices. This is because the present invention
does not require the significant trans-abdominal exertion typically
associated with those prior art devices containing a rigid shaft
element for carrying the balloon component. In the prior art
devices, the mechanics of the balloon member are typically altered
negatively over time, for example, balloon members associated with
the prior art are known to stiffen and lose their ability to
retract fully into the shaft completely. This results in the
creation of traumatizing folds that may exacerbate healing of the
stoma site upon removal or subsequent manipulation of the
catheter.
[0039] Turning now to FIG. 4, it may be seen that by giving the
trans-abdominal section, i.e., that portion of the balloon 36 that
is in contact with the stoma site 18, appropriate dimensions, the
device 10 when inflated may be enabled to produce a certain radial
force onto the trans-abdominal structures of the surgically
perforated fistula channel or stoma 18. This force would serve to
keep the penetration channel under permanent expansion and would
therefore provide an efficient seal against gastric material
leaving the stomach and entering the peritoneal cavity between the
stomach and abdominal wall 14. Moreover this feature could also
slow or stop bleeding at the site and foster a permanent and
continuous dilation of the stoma itself.
[0040] Continuing to look at FIG. 4, it may be seen that the outer
of the two concentric foil ends, in this case end 24 is dimensioned
in such a way, that the exterior surface 38 exceeds the diameter of
the stoma perforation. This may be seen by viewing that portion of
the exterior surface 38 in contact with the gastric wall 12. In
many embodiments, the surface 38 may be made to exceed the stoma
diameter by a significant amount. A significant amount may be
thought of in general terms as an amount that exceeds the widest
section of the perforation by at least about 10%, but may range
significantly higher including ranges from about 25 to about 50%
greater than the stoma diameter, and in some embodiments may range
up to about 75% greater than the stoma diameter.
[0041] Due to the material selection of the balloon, the mechanical
properties of the material, and the balloon's wall thickness, the
device 10 may be designed to function at inflation pressures that
inhibit bleeding in the stoma 18 without subjecting the foil to a
tensive or extensive force. That is, the rest of the sheath,
introverted in the transmural passage area, forms a tight closure
in this section of the device by virtue of the proposed material
wall thickness, discussed in greater detail below. This serves to
prevent the escape of gastric secretions in spite of longitudinal
folding of the exterior surface 38. Hemostatic inflation of the
device 10 precisely tailored to the particular blood flow situation
can thus be achieved in the area of the stoma perforation. When
thin-walled balloon membranes with a residual dimension are used,
the transmural force which the balloon exerts on the puncture
channel corresponds largely to the inflation pressure measurable in
the case in question.
[0042] In order to promote this radial expansion effect, the wall
thickness of the balloon 36 would likely be no greater than about
100 micrometers, especially in those regions where radial expansion
is desirable, such as at the trans-abdominal section. Even so, in
many embodiments, the balloon may be made of a soft membrane having
a wall thickness of from about 30 to about 60 micrometers. While
devices having wall thicknesses in this particular range are
well-suited for use as initial placement devices, where higher seal
forces are desired, a structurally identical device which is
anticipated to remain in place for long-term treatment could be
made of even thinner walled, less pressure resistant materials. In
such devices, it is envisioned that the outer or exterior surface
38 especially at the trans-abdominal region would not even exceed
about 50 micrometers, and may actually be thinner, in the range of
from about 10 to about 30 micrometers.
[0043] A material capable of functioning in the prescribed manner
and capable of functioning with these wall thicknesses may be
manufactured of Pellethane 2363 from DOW Chemical, a thermoplastic
polyurethane. However, other materials having similar mechanical
characteristics should work equally as well. Suitable materials
would be mechanically low-compliant and therefore stable in shape
under elevated balloon filling pressures. They would exhibit little
volume expansibility, and as such, as in the example stated above,
a polyurethane is particularly well-suited in this application.
Such materials, even under heavy traction, would not permit any
considerable shape deformation of the torus balloon and thus would
minimize the possibility that the balloon could inadvertently slip
through the gastric wall. This capability is of some importance so
as to ensure the continued reliability of the device under
conditions associated with daily use.
[0044] FIG. 5 depicts an alternative embodiment of the device 10
having a bulge 54, in this case a disc-shaped bulge, formed into
the exterior surface 38 of the balloon 36. This bulge 54, if
present, would desirably be situated proximate to the end 24 such
that it would be external to the stoma 18 and the living body 20
itself. The bulge 54 would serve as a second embodiment of the
retention mechanism 46 and it may be seen that such a feature would
counteract the force associated with the torus section of the
balloon 36 internal to the living body 20. This embodiment may
further facilitate homeostasis in the superficial wound area
immediately after the perforation of the stoma 18. Moreover, the
bulge 54 may also be desirable when a more rigid retention
mechanism 46 can not be used due to the development of ulcers or
other irritations of the skin.
[0045] In any of the aforementioned embodiments as well as in
further embodiments described below, the foil 22 may be designed so
that in the freely deployed state, that is, when the pressure
within the space 32 is equal to the ambient environmental pressure,
the exterior surface 38 of the balloon 36 at the trans-abdominal
region may have a residual diameter which allows for the infolding
of that surface 38 and thus provides for the best possible
equalization of acting force and measured inflation pressure.
[0046] Turning now to FIG. 6, it may be seen that a version of the
device 10 may be manufactured so as to place a secondary bulge 56
between the gastric wall 12 and the abdominal wall 14. Such a
device 10 would serve as a bolster against the intra-gastric
balloon 36, and thus would enable a fluid tight seal and/or a
haemostatic compression against gastric perforation when the
balloon 36 and secondary bulge 56 were inflated. This may be of
use, for example, in situations in which a patient has suffered a
severe perforation and its associated bleeding. The device of FIG.
6 would enable the clinician to perform efficient compression of
the puncture site. That portion of the device which would serve as
the anchor or retention mechanism external to the living body 20
may consist of the bulge 54 or of a retention mechanism 46 similar
to that shown in FIGS. 1 or 4.
[0047] FIG. 7 shows yet a further alternative version of the device
10. The FIG. 7 embodiment depicts the torus shaped balloon 36
portion as being established inside the gastric wall 12 yet has no
direct anchoring capability outside the abdominal wall 14. Such an
intra-abdominal device grants free abdominal movement of the
perforated organ and would also enable gastric access, yet the
gastric wall 12 and the abdominal wall 14 would not be brought into
direct contact and would thus not fuse to one another. This may be
desirable for some medical or anatomical reasons. In this example,
the device would be connected to the body outside through a hose
connection.
[0048] As shown in FIGS. 5 through 7 the catheter may be used in
any of the embodiments, including the others described herein. In
particular, having the ability to slide a catheter 52 through the
bore 50 and passage 42 into the stomach or other site internal to
the living body 20 would be beneficial in cases of long-term use,
as the catheter 52 could be changed simply and atraumatically, i.e.
without damaging the puncture channel, and it could be accomplished
even by a trained layperson.
[0049] Referring to FIG. 8 there is shown a cross-sectional view of
still another embodiment of the present invention. This embodiment
is similar to the previous embodiments in that the balloon 36 may
be configured similarly to any of the balloon embodiments described
above. Like the prior embodiments, the FIG. 8 embodiment includes
the thin foil 22 having a length 28 terminating in the first and
second ends 24 and 26. Additionally, one end is backfolded or
introverted with respect to the other so as to create the space 32
that forms the balloon 36 between the two ends 24 and 26
respectively. However, FIG. 8 depicts yet a third embodiment of the
retention mechanism 46. In that FIG. 8 forms a more detailed
cross-sectional view of one possible embodiment, a number of items
are described as pertaining to FIG. 8. It should be noted that
these items may also be found on other embodiments, including those
described above. Those items not capable of being utilized on
previous embodiments will be specifically noted.
[0050] In more general terms, this embodiment integrates the
retention mechanism 46 into the cap 30 itself. As such, the two
components may be thought of as forming a head 58. The head 58
serves at least in part to capture the ends 24 and 26 but also
serves to contain a valve or valves which are used to regulate the
flow of fluids through the entire device 10. As such, the head 58
may be made of a medical grade silicone but should be sufficiently
designed to capture the foil ends 24 and 26 without undue failure.
As is the case with each embodiment of the retention mechanism 46,
the head 58 also serves to prevent the device 10 from completely
advancing through the stoma 18 and into the stomach or intestine of
the living body 20.
[0051] A first of said valves would serve as the port 34 and as
such would be adapted to couple the space 32 with the inflation
source or mechanism 44. As in the previous embodiments, the port 34
would serve as a means to inject fluids into or remove fluids from
the space 32 forming the interior of the balloon 36. A lumen 60 may
be provided that leads from the port 34 to the space 32. Such a
lumen 60 though not shown may be desirable on each of the other
embodiments. As would be apparent, control of the inflation
mechanism 44 through the port 34 enables the user or a physician,
etc., to selectively control inflation and deflation of the balloon
36. To assist in this, a releasable one-way valve 62 may be
disposed between the space 32 and the port 34, for example in the
lumen 60. Appropriate valves capable of serving in this function
are known and would be understood by those having skill in the art
and may be actuated by means of a syringe.
[0052] A second of said valves, if provided, may be situated in the
bore 50 located in the head 58 and would enable the injection of
enteral feeding solution, etc., through the device 10 and into the
user. The valve may comprise an anti-reflux valve 64 which is
configured to allow nutrient solutions, etc., to pass into the
user, but to prevent the flow of fluids out of the user unless
properly engaged by a syringe or other sampling device having a
nipple which corresponds to the anti-reflux valve. The anti-reflux
valve 64 would be disposed such that it is in communication with
the passage 42.
[0053] Looking now to FIG. 9, the FIG. 8 embodiment is depicted in
conjunction with an insertion device 66. The insertion device 66
may be configured as a user manipulable introducer 68 having a
hollow probe 70 at one end. The probe 70 may be tapered at a distal
end 72 to allow ease of passage through the stoma 18 so as to
minimize aggravation of the tissue. A proximal end 74 of the probe
70 may also be tapered to allow subsequent withdrawal of the probe
70 from the stoma 18 with m al tissue damage as well. Protruding
from the proximal end 74 is an extension rod 76 adapted to be
grasped by the user, physician, or clinician. The rod 76 may be
configured as a hollow cannula so as to be deployable over a guide
wire (not shown) previously placed within the living body 20.
[0054] Prior to installation in the living body 20, the foil 22 is
captured within a cavity 78 formed in the hollow probe 70. The
extension rod 76 is situated so as to extend from the cavity 78,
through the passage 42 and the bore 50, and ultimately extend
outward through the head 58. A capturing element 80 is designed to
be slid over the extension rod 76 and seated within the bore 50 in
the head 58. By ensuring that the capturing element 80 is held in
contact with the foil 22, which in turn is pressed against proximal
end 74 of the probe 70, the insertion device 66 may be placed in
situ within the cavity.
[0055] Once the foil 22 is in place, the user would continue to
advance the probe 70 deeper into the living body 20 until the foil
22 is adequately deployed from the cavity 78. Prior to or during
this step, the capturing element 80 may be removed from the
extension rod 76 or at least backed away from the probe 70. This
may all be accomplished by manipulation of the extension rod 76.
Subsequent inflation of the balloon 36 would ensure that the foil
22 is completely free of the cavity 78. After the balloon 36 is
inflated, the probe 70 may be withdrawn from the living body by
backing it out through the passage 42 and the bore 50, and
ultimately completely removing it from the device 10.
[0056] Finally, FIG. 10 has been included to address ventilation of
the living body 20. In FIG. 10, it may be seen that the channel 42
contained within the balloon 36 may be shaped in order to prevent
its total collapse into the tape-like structure. That is, by
manufacturing the end 26 as well as a portion of the interior
surface 40 to a given foil wall thickness, one can prevent a total
collapse of the channel 42, and instead it is possible to form one
or more laterally positioned tubular paths 82. These tubular paths
82 would serve to grant a permanent, noncollapsible passageway for
gases. The diameter of the resulting tubular paths 82 may be
configured by choosing an appropriate wall thickness of the foil
22. Alternatively a tubular reinforcement exhibiting an appropriate
stiffness may be inserted and permanently affixed within the
channel 42. This may be desirable in instances as described above
where a patient having an existing anatomical or functionally
insufficient communication between the stomach and the ambient
surrounding of the patient requires the release of accumulating
stomach gases
[0057] As used herein and in the claims, the term "comprising" is
inclusive or open-ended and does not exclude additional unrecited
elements, compositional components, or method steps.
[0058] While various patents have been incorporated herein by
reference, to the extent there is any inconsistency between
incorporated material and that of the written specification, the
written specification shall control. In addition, while the
invention has been described in detail with respect to specific
embodiments thereof, it will be apparent to those skilled in the
art that various alterations, modifications and other changes may
be made to the invention without departing from the spirit and
scope of the present invention. It is therefore intended that the
claims cover all such modifications, alterations and other changes
encompassed by the appended claims.
* * * * *